The FDA classified the recall of the St. Jude Medical’s Riata and Riata ST silicone defibrillation leads as a Class I recall, according to St. Jude Medical. The recall is due to the potential risk of serious injury or patient death if affected devices malfunction.
The FDA action follows St. Jude Medical’s issuance of a voluntary medical device advisory letter to physicians on Nov. 28 that addressed Riata (8Fr) models 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, 1592; and Riata ST (7Fr) models 7000, 7001, 7002, 7010, 7011, 7040, 7041 and 7042. In a statement, the FDA noted that the recall classification is standard after an advisory is sent by a device manufacturer to physicians.
St. Paul, Minn.-based St. Jude Medical is undergoing a prospective study to evaluate the incidence and long-term performance of externalized conductors that do not show electrical abnormalities. The company encourages physicians to report all leads with an externalized conductor, with or without an associated electrical abnormality, to its technical services department.